We've come a long way, maybe: Recruitment of women and analysis of results by sex in clinical research

During the last decade, North American policymakers have started to demand more representative research populations. Several papers have suggested that there has been improvement, over the last decade, in the number of studies that include women as subjects, yet these same papers have expressed concern that many investigators omit analysis of data by sex from their research reports. Our study examined all clinical research ethics applications from July 1, 1995, to June 30, 2000, at a tertiary care Canadian university teaching hospital to determine whether the investigator planned to recruit both men and women and whether he or she intended to perform analysis of data by sex. For research studying nonsex-specific conditions, 97.6% of researchers intended to recruit both men and women, yet only 20.2% planned to perform analysis of data by sex. This proportion decreased from 29.9% in 1995-1996 to 16.9% in 1999-2000. Seventy-seven percent of the applications submitted were for studies involving drugs, and only 17% of these nonsex-specific studies planned an analysis of data by sex. The results of this study indicate that although researchers in Canada are aware of the importance of planning to recruit women into clinical trials, more needs to be done to ensure that they plan and perform analyses of data by sex.